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出境医 / 临床实验 / The ProVerum First in Man PROVE Study

The ProVerum First in Man PROVE Study

Study Description
Brief Summary:
A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: The ProVee Urethral Expander System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomised, single centre, safety and feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ProVerum First in Man PROVE Study
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 15, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Group
The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms
 Device: The ProVee Urethral Expander System
The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.
Other Name: The ProVee Expander
Outcome Measures
Primary Outcome Measures :
  1. Deployment of the Implant [ Time Frame: Immediately after the implant deployment procedure ]
    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy

  2. Expansion of the Implant [ Time Frame: Within 24 hours of the implant deployment procedure ]
    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT


Secondary Outcome Measures :
  1. Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period [ Time Frame: Immediately after the implant deployment procedure, within 24 hours ]
  2. Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years [ Time Frame: 2 years ]
  3. Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms [ Time Frame: 2 years ]
    Change in symptom score using the Improvement in International Prostate Symptom Score and Quality of Life score instrument within the 2 year follow up period

  4. Preliminary assessment of the effectiveness of the procedure in improving urinary flow [ Time Frame: 2 years ]
    Change in Qmax measurement within the 2 year follow up period


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males ≥ 50 years of age
  • Moderate-to-severe symptomatic BPH
  • IPSS of > 15
  • Peak urinary flow rate (Qmax) of <12 mL/s
  • Prostate volume of ≥ 30 and ≤80 cc
  • Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

  • A prostatic urethral length of less than 4cm
  • A prostatic volume <30cc or >80cc
  • An obstructing intravesical prostatic median lobe
  • Urinary incontinence due to an incompetent external sphincter
  • Urethral pathologies that may prevent insertion of delivery system
  • A current symptomatic urinary tract infection
  • Current significant visible haematuria
  • Patients with known allergy to nickel or titanium
  • History of significant medical co-morbidity or prior surgery that may confound the results of the Study
  • Another medical condition that would pose an unacceptable patient risk
  • Known or suspected urological condition that may affected voiding function
  • Neurogenic bladder and/or sphincter abnormalities
  • Patients with cognitive disabilities unable to understand and give informed consent to the research study
Contacts and Locations

Locations
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Australia, Victoria
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
ProVerum Medical
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Deployment of the Implant [ Time Frame: Immediately after the implant deployment procedure ]
    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy
  • Expansion of the Implant [ Time Frame: Within 24 hours of the implant deployment procedure ]
    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period [ Time Frame: Immediately after the implant deployment procedure, within 24 hours ]
  • Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years [ Time Frame: 2 years ]
  • Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms [ Time Frame: 2 years ]
    Change in symptom score using the Improvement in International Prostate Symptom Score and Quality of Life score instrument within the 2 year follow up period
  • Preliminary assessment of the effectiveness of the procedure in improving urinary flow [ Time Frame: 2 years ]
    Change in Qmax measurement within the 2 year follow up period
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period [ Time Frame: Immediately after the implant deployment procedure, within 24 hours ]
  • Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years [ Time Frame: 2 years ]
  • Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms [ Time Frame: 2 years ]
    Reduction in symptom score using the IPSS/QoL score instrument within the 2 year follow up period
  • Preliminary assessment of the effectiveness of the procedure in improving urinary flow [ Time Frame: 2 years ]
    Increase in Qmax measurement within the 2 year follow up period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The ProVerum First in Man PROVE Study
Official Title  ICMJE The ProVerum First in Man PROVE Study
Brief Summary A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, non-randomised, single centre, safety and feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE Device: The ProVee Urethral Expander System
The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.
Other Name: The ProVee Expander
Study Arms  ICMJE Experimental: Treatment Group
The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms
Intervention: Device: The ProVee Urethral Expander System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 3, 2020) 		10
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		12
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males ≥ 50 years of age
  • Moderate-to-severe symptomatic BPH
  • IPSS of > 15
  • Peak urinary flow rate (Qmax) of <12 mL/s
  • Prostate volume of ≥ 30 and ≤80 cc
  • Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

  • A prostatic urethral length of less than 4cm
  • A prostatic volume <30cc or >80cc
  • An obstructing intravesical prostatic median lobe
  • Urinary incontinence due to an incompetent external sphincter
  • Urethral pathologies that may prevent insertion of delivery system
  • A current symptomatic urinary tract infection
  • Current significant visible haematuria
  • Patients with known allergy to nickel or titanium
  • History of significant medical co-morbidity or prior surgery that may confound the results of the Study
  • Another medical condition that would pose an unacceptable patient risk
  • Known or suspected urological condition that may affected voiding function
  • Neurogenic bladder and/or sphincter abnormalities
  • Patients with cognitive disabilities unable to understand and give informed consent to the research study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972371
Other Study ID Numbers  ICMJE CIP-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ProVerum Medical
Study Sponsor  ICMJE ProVerum Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ProVerum Medical
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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